# FDA recall Z-0555-2025

> **WINGDERM ELECTRO-OPTICS LTD.** · Class II · device recall initiated 2024-08-23.

## Product

Non-ablative Fractional Laser Systems, Model: WFB-01

## Reason for recall

Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-0555-2025
- **Recalling firm:** WINGDERM ELECTRO-OPTICS LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-23
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Beijing, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0555-2025

## Citation

> AI Analytics. FDA recall Z-0555-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0555-2025. Source: US FDA. Licensed CC0.

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